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`Paper _____
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`UNITED STATES PATENT AND TRADEMARK OFFICE
`_______________
`
`BEFORE THE PATENT TRIAL AND APPEAL BOARD
`_____________
`
`STEADYMED LTD.
`
`Petitioner
`
`v.
`
`UNITED THERAPEUTICS CORPORATION
`
`Patent Owner
`
`
`U.S. Patent No. 8,497,393
`Issue Date: Jul. 30, 2013
`Title: PROCESS TO PREPARE TREPROSTINIL, THE ACTIVE
`INGREDIENT IN REMODULIN®
`_______________
`
`Case IPR2016-00006
`_______________
`
`PATENT OWNER’S AMENDED MOTION TO FILE UNDER SEAL
`(AMENDMENT TO PAPER NO. 18)
`
`Mail Stop “PATENT BOARD”
`Patent Trial and Appeal Board
`U.S. Patent and Trademark Office
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`4826-5595-5773.1
`
`
`
`IPR2016-00006
`Patent 8,497,393
`
`
`
`Pursuant to 37 C.F.R. § 42.14 and the E-mail communication of the Patent
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`Trial and Appeal Board (“Board”) dated November 23, 2016, United Therapeutics
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`Corporation (“Patent Owner”) hereby submits this Amended Motion to File Under
`
`Seal in order to exclude certain materials that Patent Owner intends to include in its
`
`demonstratives for the Final Hearing scheduled to be held on November 29, 2016.
`
`In Joint Motion to File Under Seal previously filed on April 21, 2016, Patent
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`Owner and Steadymed Ltd. (“Petitioner”) had jointly moved to seal certain
`
`portions of the Decision to Institute. In the present amended motion, Patent Owner
`
`moves to retain sealed status of all information in the prior motion except for the
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`information in page 20, line 13, which was previously held confidential.
`
`Accordingly, a redacted version of the Decision to Institute is submitted
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`herewith, identifying the specific parts of the Decision to Institute that should
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`remain under seal, which are found at:
`
`On page 20, lines 3, 5, 8-10, and 13-17, and footnote 7, lines 1-2; and
`
`On page 21, lines 1-3 and 6-8.
`
`I. Good Cause Exists for Sealing Certain Confidential Information
`The Office Patent Trial Practice Guide provides that “the rules aim to strike
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`a balance between
`
`the public’s
`
`interest
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`in maintaining a complete and
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`understandable file history and the parties’ interest in protecting truly sensitive
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`information.” 77 Fed. Reg. 48756, 48760 (Aug. 14, 2012). These rules
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`2
`4826-5595-5773.1
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`
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`“identify confidential information in a manner consistent with Federal Rule of
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`Civil Procedure 26(c)(1)(G), which provides for protective orders for trade secret
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`or other confidential research, development, or commercial information.” Id.
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`(citing 37 C.F.R. § 42.54).
`
`On page 20, lines 3, 5, 8-10, and 13-17 and footnote 7, lines 1-2, the Decision
`
`to Institute discusses specific data from Exhibits 2003-2006 submitted to and held
`
`in confidence by the FDA (the reasons why this information should be sealed are
`
`presented below).
`
`Finally, on page 21, lines 1-3 and 6-8, the Decision to Institute discusses
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`specific data from Exhibit 2006 submitted to and held in confidence by the FDA
`
`(the reasons why this information should be sealed are presented below) and
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`compares it to certain data in Exhibit 1002.
`
`Exhibit 2003 is a confidential communication from the FDA to Patent Owner
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`approving a process change in the manufacture of Patent Owner’s proprietary
`
`Remodulin® product. Exhibit 2004 is a process validation report (Protocol No.
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`“VAL-00131”) that provides confidential information about the manufacture of
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`Remodulin®. Exhibit 2005 is a Process Optimization Report that provides
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`confidential information about the manufacture of Remodulin®. Exhibit 2006 is a
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`confidential communication from the Patent Owner t o t h e F D A regarding
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`the manufacturing of Remodulin®.
`
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`4826-5595-5773.1
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`3
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`
`
`IPR2016-00006
`Patent 8,497,393
`
`
`Exhibits 2003-2006 contain information about the manufacturing process for
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`Remodulin®. Such information could be improperly used by competitors to gain
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`unfair business and competitive advantage with customers in the marketplace,
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`including using details of Patent Owner’s process for competitive commercial
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`products. The entireties of Exhibits 2003-2006 relate to highly confidential
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`manufacturing process details for Remodulin®, as discussed with FDA and
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`presently held in confidence by FDA.
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`Exhibits 2003-2006 were produced in a litigation (United Therapeutics
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`Corp. v. Sandoz, Inc., Civ. No. 14-cv-05499) as confidential documents and
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`remain under seal in the litigation. The information contained in Exhibits
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`2003-2006 is also held in confidence by the FDA.
`
`The Board has granted a Motion to Seal certain exhibits in their entireties for
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`similar reasons in Purdue Pharma L.P. v. Depomed, Inc., IPR2014-00377, paper
`
`no. 62 at 4-6, (PTAB March 17, 2015), where “Patent Owner avers that the ‘highly
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`confidential nature of’ the information contained in those documents makes it
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`‘impossible to reasonably redact [them] for public disclosure.’” Id. at 4.
`
`II. Certification of Non-Publication
`
`On behalf of Patent Owner and Petitioner, undersigned counsels certify that,
`
`to the best of their knowledge, the information sought to be sealed by this Joint
`
`Motion to Seal has not been published or otherwise made public. Efforts to
`4
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`4826-5595-5773.1
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`maintain the confidentiality of this information have also been undertaken by
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`Patent Owner in the related district court proceeding and with the FDA, and such
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`information currently is under seal in that litigation and at the FDA.
`
`III. Conclusion
`For the reasons stated above, Patent Owner and Petitioner respectfully
`
`request that the portions indicated herein of the Decision to Institute remain under
`
`seal and only the accompanying redacted version of the Decision to Institute be
`
`made available to the public.
`
`Date: Nov. 23, 2016
`
`Respectfully submitted,
`
`/Stephen B. Maebius/
`Stephen B. Maebius
`Reg. No. 35,264
`Counsel for Patent Owner
`
`
`
`
`
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`4826-5595-5773.1
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`5
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`
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`IPR2016-00006
`Patent 8,497,393
`
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`CERTIFICATE OF SERVICE
`
`The undersigned hereby certifies that a copy of the foregoing Patent Owner’s Amended
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`Motion to Seal and accompanying exhibit, was served on counsel of record for Petitioner on Nov.
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`23, 2016 by delivering a copy via email to Stuart Pollack and Lisa Haile (the counsel of record for
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`the Petitioner) at the following address:
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`Steadymed-IPR@dlapiper.com
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`
`
`
`
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`Date: Nov. 23, 2016
`
`
`
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`
`
`
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`signature: /Stephen B. Maebius/
`
` Stephen B. Maebius
`
`
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`4826-5595-5773.1
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`6
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`
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